Supporting better use of medicines

The European Medicines Agency (EMA) has released a draft scientific guideline that outlines how post-authorisation efficacy studies (PAES) should be designed by companies to support regulatory decision making in the European Union (EU). In addition, a guidance that describes the regulatory aspects for the fulfilment of imposed PAES is also published.

Original source


Register for receiving PharmaAround news, register for PharmAround events.
Continue registration